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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B109. INVESTIGATIONAL DEVICE EXEMPTIONS |
Section 22-B10926. DISQUALIFICATION OF A CLINICAL INVESTIGATOR
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10926.1If the Department has information indicating that an investigator has repeatedly or deliberately failed to comply with the requirements of Chapter 109 or 21 C.F.R., parts 50 or 56, or has repeatedly or deliberately submitted false information either to the sponsor of the investigation or in any required report, the Department will furnish the investigator written notice of the matter under complaint and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the Department, the disqualification process will be terminated. If an explanation is offered but not accepted by the Department, the investigator will be given an opportunity for a regulatory hearing before the Department on the question of whether the investigator is entitled to receive investigational devices.
10926.2After evaluating all available information, including any explanation presented by the investigator, if the Department determines that the investigator has repeatedly or deliberately failed to comply with the requirements of Chapter 109 or 21 C.F.R., parts 50 or 56, or has deliberately or repeatedly submitted false information either to the sponsor of the investigation or in any required report, the Department will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing IRB that the investigator is not entitled to receive investigational devices. The notification will provide a statement of basis for such determination.
10926.3Each IDE and each cleared or approved application submitted under §§ 10512 through 10521 or Chapters 106 or 109 of this subtitle containing data reported by an investigator who has been determined to be ineligible to receive investigational devices will be examined to determine whether the investigator has submitted unreliable data that are essential to the continuation of the investigation or essential to the approval or clearance of any marketing application.
10926.4If the Department determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Department will notify the sponsor who shall have an opportunity for a regulatory hearing. If a danger to the public health exists, however, the Department shall terminate the IDE immediately and notify the sponsor and the reviewing IRB of the determination. In such case, the sponsor shall have an opportunity for a regulatory hearing before the Department on the question of whether the IDE should be reinstated.
10926.5If the Department determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued clearance or approval of the marketing application for which the data were submitted cannot be justified, the Department will proceed to withdraw approval or rescind clearance of the medical device in accordance with the applicable provisions of the Act.
10926.6An investigator who has been determined to be ineligible to receive investigational devices may be reinstated as eligible when the Department determines that the investigator has presented adequate assurances that the investigator will employ investigational devices solely in compliance with the provisions of Chapter 109 or 21 C.F.R., parts 50 or 56.